BACTAFUZ Fusidic Acid Cream 2% ww

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

FUSIDIC ACID

Boleh didapati daripada:

PAHANG PHARMACY SDN. BHD.

INN (Nama Antarabangsa):

FUSIDIC ACID

Unit dalam pakej:

15 gm

Dikeluarkan oleh:

ENCUBE ETHICALS PVT LTD

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
BACTAFUZ FUSIDIC ACID CREAM 2% W/W
Fusidic Acid (micronized) 2% w/w
1
WHAT IS IN THIS LEAFLET
1.
What
BACTAFUZ
(Fusidic Acid
Cream BP 2% w/w) is used for
2.
How
BACTAFUZ
works
3.
Before you use
BACTAFUZ
4.
How to use
BACTAFUZ
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
BACTAFUZ
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
1.
WHAT BACTAFUZ IS USED FOR
BACTAFUZ
is indicated for the
treatment of skin infections caused
by
_Staphylococci, Streptococci, _
_Propionibacterium acnes, _
_Corynebacterium minutissimum_
and
other organisms sensitive to
fusidic acid. The most important
indications being:
•
Impetigo (a weeping, crusty and
swollen patch of skin),
•
Infected wounds,
•
Folliculitis (inflammation of the
hair follicles),
•
Boils (deep, localized skin
infections that begin as
reddened,aore areas),
•
Sycosis barbae (infection of the
chin or bearded region),
•
Carbuncles (painful and
contagious clusters of boils),
•
Hidradenitis (chronic skin
disease characterized by
recurrent boil-like lumps
(nodules) under the skin),
•
Paronychia (soft tissue infection
around a fingernail),
•
Erythrasma (conditions
affecting the skin folds such as
under the arms, in the groin and
between the toes)
BACTAFUZ
is an invisible, non-
staining preparation, which is
cosmetically acceptable for
treatment of face and scalp
infections.
2.
HOW BACTAFUZ WORKS
BACTAFUZ
contains Fusidic acid.
It
is
a
type
of
antibiotic.
BACTAFUZ
works
by
killing
germs
(bacteria)
that
cause
infections.
3.
BEFORE YOU USE BACTAFUZ
-
_When you must not use it _
Do not use
BACTAFUZ
•
If
you
are
allergic
to
Fusidic
acid
or
any
of
the
other
ingredients
of
this
medicine
listed at the end of this leaflet.
•
If you are pregnant or breast-
feeding,
think
you
may
be
pregnant or are planning to have
a
baby,
ask
your
doctor
or
pharmacist
for
advice
before
using this medicine. Tell your
doctor if you become pregnant
while using this medi

Ciri produk

BACTAFUZ
Fusidic Acid Cream 2% w/w
PRODUCT NAME:
BACTAFUZ
: Fusidic Acid Cream 2% w/w
NAME AND STRENGTH OF ACTIVE INGREDIENTS:
BACTAFUZ:
Each gram contains: Fusidic acid Ph. Eur. 20mg, Potassium Sorbate Ph.
Eur. (As preservative) 2.7mg
PRODUCT DESCRIPTION:
BACTAFUZ
: White, smooth, homogenous cream.
PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMICS PROPERTIES
PHARMACOTHERAPEUTIC GROUP: OTHER ANTIBIOTICS FOR TOPICAL USE; ATC
CODE: D06AX01
Fusidic acid is a potent antibacterial agent. Fusidic acid and its
salts show fat and water solubility and strong surface activity
and exhibit unusual ability to penetrate intact skin. Concentrations
of 0.03 - 0.12 mcg Fusidic acid per ml inhibit nearly all
strains of
_Staphylococcus aureus_
. Topical application of Fusidic acid is also effective against
_Streptococci, Corynebacteria, _
_Neisseria_
and certain
_Clostridia._
PHARMACOKINETICS PROPERTIES
In vitro studies show that Fusidic acid can penetrate intact human
skin. The degree of penetration depends on factors such as
the duration of exposure to Fusidic acid and the condition of the
skin. Fusidic acid is excreted mainly in the bile with little
excreted in the urine.
INDICATIONS:
BACTAFUZ
is indicated for the treatment of skin infections caused by
_Staphylococci, Streptococci, Propionibacterium _
_acnes, Corynebacterium minutissimum_
and other organisms sensitive to fusidic acid. The most important
indications being
impetigo, infected wounds, folliculitis, boils, sycosis barbae,
carbuncles, hidradenitis, paronychia and erythrasma
BACTAFUZ
is an invisible, non staining preparation, which is cosmetically
acceptable for treatment of face and scalp
infections.
RECOMMENDED DOSAGE:
For external use only.
Apply to the affected area 2-3 times daily, generally for a period of
7 days, except in treatment of acne where therapy should
be extended for a longer period according to the nature of the disease
CONTRAINDICATIONS:
Hypersensitivity to the active substance or to any of the excipients.
WARNING AND PRECAUTIONS:
Bacterial resistance amon